On November 2, 2022 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and financial results for the third quarter of 2022 (Press release, Morphic Therapeutic, NOV 2, 2022, View Source [SID1234622898]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Third Quarter 2022 and Recent Corporate Highlights
Completed target enrollment ahead of schedule for the main cohort of 30 patients in the EMERALD-1 (MORF-057-201), an open-label phase 2a multi-center study of patients with moderate to severe ulcerative colitis (UC) receiving 100 mg BID of MORF-057
Primary endpoint data from the EMERALD-1 main cohort expected second quarter of 2023
The original target of 30 patients in the main cohort will be exceeded as Morphic plans to include eligible patients who were in screening at the time of the 30th patient being enrolled, per protocol allowance and ethical trial conduct
An exploratory cohort of up to 10 patients who have previously failed treatment with advanced UC therapies is ongoing
Affirmed that EMERALD-2 (MORF-057-202), a global phase 2b randomized double-blind placebo-controlled trial of MORF-057, is planned to begin dosing patients in the fourth quarter of 2022
Patients will be randomized to receive one of three active arms or a placebo arm
MORF-057 100 mg BID (twice daily) arm
MORF-057 200 mg BID arm
MORF-057 QD (once daily) dose arm
Placebo (to cross over to MORF-057 after induction phase)
The primary endpoint of this study is clinical remission rate as measured by the modified Mayo score at 12 weeks
Secondary endpoints will include change in Robarts Histopathological Index (RHI), pharmacokinetic and pharmacodynamic measures as well as safety parameters
Following the 12-week induction phase, patients will move to a 40-week maintenance phase
Top line data, including the primary endpoint results of EMERALD-2, are expected in the first half of 2025
Presented new data at United European Gastroenterology (UEG) Week 2022 providing deeper information on the safety and dose-activity relationship of MORF-057, including A4B7 receptor saturation and statistically significant increases in key circulating T lymphocyte populations at multiple doses
Presented new data on MORF-057 at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting that further reinforce and build upon the favorable pharmacokinetic and pharmacodynamic profile for MORF-057 seen in previous studies
Noted pioneering achievements by members of the Morphic Team
Applauded Dr. Albert Lin and Dr. Timothy Springer for their recent publication in Cell describing key conformation changes integrin receptors; a discovery that led to the formation of Morphic Therapeutic
Celebrated the award of the 2022 Albert Lasker Basic Medical Research Award to Dr. Timothy Springer for his role in the discovery of the integrin receptor
"Excellent efforts by the Morphic Team have led to major advances in the MORF-057 phase 2 program, with the EMERALD-1 phase 2a study completing enrollment ahead of schedule and the EMERALD-2 phase 2b study now poised to commence," commented Praveen Tipirneni, MD, Chief Executive Officer of Morphic Therapeutic. "We are excited for clinical progress during the remainder of 2022 and especially looking forward to 2023."
Financial Results for the Third Quarter 2022
Net loss for the quarter ended September 30, 2022 was $30.0 million or $0.78 per share compared to a net loss of $25.0 million or $0.69 per share for the same quarter last year
Revenue was $2.1 million for the quarter ended September 30, 2022, compared to $3.1 million for the same quarter last year
Research and development expenses were $25.2 million for the quarter ended September 30, 2022, as compared to $21.0 million for the same quarter last year. The increase was primarily attributable to higher clinical and development costs along with higher pre-clinical and phase 2 clinical trial costs to support our lead product candidate MORF-057
General and administrative expenses were $8.3 million for the quarter ended September 30, 2022, compared to $7.3 million for the same quarter last year. The increase was due to increased non-cash stock-based compensation expense and higher payroll costs
As of September 30, 2022, Morphic had cash, cash equivalents and marketable securities of $371.8 million, compared to $397.6 million as of June 30, 2022. Morphic believes its cash, cash equivalents and marketable securities as of September 30, 2022, will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2025.